Restrictions on pharmacist dispensing of mifepristone remain a hard pill to swallow
Bibliographic record
Abstract
Abstract This analysis explores the basis for the US Food and Drug Administration (FDA) requiring a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone for the termination of intrauterine pregnancy. Controversies surround mifepristone and its REMS. The safety and efficacy of mifepristone are briefly reviewed with respect to FDA's actions. It is difficult to justify the continued requirement for a REMS for mifepristone by applying the regulatory framework and considering mifepristone's safety record. Drugs with higher risks are on the US market without an FDA‐mandated REMS. Canada removed all restrictions on the use of mifepristone for abortion, which has not resulted in patient safety concerns. All pharmacists should be permitted to dispense mifepristone. The continued requirement for a mifepristone REMS in the US appears to be based more on politics rather than evidence.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.037 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.005 | 0.003 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.017 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".